ONC gets new authority over health IT certification

By Chase Gunter

Oct 17, 2016

Under a new rule, the Office of the National Coordinator for Health Information Technology will have more authority to review the safety and reliability of the electronic health records systems of health care providers.

ONC, a Department of Health and Human Services agency, is responsible for certifying health IT products for use in incentive programs offered under Medicare and Medicaid. Since the Health Information Technology for Economic and Clinical Health passed in 2009 as part of the larger stimulus package. ONC has distributed more than $25 billion in subsidies to promote the adoption of electronic health records, move the health care industry away from paper records and usher in an era of digital interoperability.

The new rule is a "key part of our commitment to accelerating interoperability and supporting reliable and safe use of health IT," said National Coordinator Dr. Vindell Washington in an Oct. 14 call with reporters.

Set to be published Oct. 19, the new ONC rule establishes guidelines for reviewing health IT products for safety in the event that certifications require capabilities outside the depth of the accredited third parties used to review health IT, or if those authorized certification bodies require information that is unavailable to them. Under certain circumstances, ONC can seek suspension or termination of certifications.

"Under this regulatory framework, if the core usability itself is contributing to unsafe conditions, then ONC could take action,” said Washington. Although the "actual triggering of direct oversight will be relatively rare," ONC does have help lines in place for concerns within the marketplace, such as problems with software, he said.

"If a product is not only unusable, but has negative effects, that's where we draw the line,” he continued, adding the ONC was "not gearing up" to assign grades to the usability of medical products. Such a grading system for usability is "not really a place you want a strong federal arm," he said.

The rule also provides ONC with greater supervision over testing labs and allows it to address performance concerns in a timely way by linking the testing labs and certification bodies. “We’re trying to put them both in line,” said Washington.

It's unclear what this could mean for providers using suspended or decertified systems.

The College of Healthcare Information Management Executives said in a statement that it "appreciates that steps that the agency is taking to increase transparency of health IT performance. Hospitals and clinicians must have confidence that the products they purchase work as intended and do not pose a significant risk to patient safety or public health."

While the rule is intended to promote interoperability, ONC does not see it as a way to punish health IT vendors whose products and services throw up barriers to information sharing. "Information blocking is bad for our patients, but that’s not particularly the focus on this rule," he said, noting that there are other levers in place to address information blocking.

Data blocking and interoperability were addressed in a regulation arising from the Medicare Access and CHIP Reauthorization Act of 2015. The MACRA rule, also released publically on Oct. 14, gives financial incentives to practitioners billing government payers to use certified health technology.

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